Cleared Traditional

K112768 - CALYPSO SYSTEMS WITH DYNAMIC EDGE GATING

K112768 is an FDA 510(k) clearance for CALYPSO SYSTEMS WITH DYNAMIC EDGE GATING, manufactured by Calypso Medical Technologies, Inc.. The device is a Class 2 Radiology device with product code LHN cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K112768 · Calypso Medical Technologies, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2011
Decision
57d
Days
Class 2
Risk

K112768 is an FDA 510(k) clearance for the CALYPSO SYSTEMS WITH DYNAMIC EDGE GATING. Classified as System, Radiation Therapy, Charged-particle, Medical (product code LHN), Class II - Special Controls.

Submitted by Calypso Medical Technologies, Inc. (Seattle, US). The FDA issued a Cleared decision on November 18, 2011 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K112768

510(k) Number K112768 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2011
Decision Date November 18, 2011
Days to Decision 57 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 107d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LHN Device Classification - Class 2, Special Controls

Product Code LHN System, Radiation Therapy, Charged-particle, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - LHN System, Radiation Therapy, Charged-particle, Medical

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Download PDF FDA Summary Calypso Medical Techn…